Clinical studies with oral lipid based formulations of poorly soluble compounds

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Clinical studies with oral lipid based formulations of poorly soluble compounds. / Fatouros, Dimitrios; Karpf, Ditte M; Nielsen, Flemming S; Mullertz, Anette.

In: Therapeutics and Clinical Risk Management, Vol. 3, No. 4, 2007, p. 591-604.

Research output: Contribution to journal › Journal article › Research › peer-review

Harvard

Fatouros, D, Karpf, DM, Nielsen, FS & Mullertz, A 2007, 'Clinical studies with oral lipid based formulations of poorly soluble compounds', Therapeutics and Clinical Risk Management, vol. 3, no. 4, pp. 591-604.

APA

Fatouros, D., Karpf, D. M., Nielsen, F. S., & Mullertz, A. (2007). Clinical studies with oral lipid based formulations of poorly soluble compounds. Therapeutics and Clinical Risk Management, 3(4), 591-604.

Vancouver

Fatouros D, Karpf DM, Nielsen FS, Mullertz A. Clinical studies with oral lipid based formulations of poorly soluble compounds. Therapeutics and Clinical Risk Management. 2007;3(4):591-604.

Author

Fatouros, Dimitrios ; Karpf, Ditte M ; Nielsen, Flemming S ; Mullertz, Anette. / Clinical studies with oral lipid based formulations of poorly soluble compounds. In: Therapeutics and Clinical Risk Management. 2007 ; Vol. 3, No. 4. pp. 591-604.

Bibtex

@article{46c70af0c5f211dd9473000ea68e967b,
title = "Clinical studies with oral lipid based formulations of poorly soluble compounds",
abstract = "This work is an attempt to give an overview of the clinical data available on lipid based formulations. Lipid and surfactant based formulations are recognized as a feasible approach to improve bioavailability of poorly soluble compounds. However not many clinical studies have been published so far. Several drug products intended for oral administration have been marketed utilizing lipid and surfactant based formulations. Sandimmune((R)) and Sandimmune Neoral((R)) (cyclosporin A, Novartis), Norvir((R)) (ritonavir), and Fortovase((R)) (saquinavir) have been formulated in self-emulsifying drug delivery systems (SEDDS). This review summarizes published pharmacokinetic studies of orally administered lipid based formulations of poorly aqueous soluble drugs in human subjects. Special attention has been paid to the physicochemical characteristics of the formulations, when available and the impact of these properties on the in vivo performance of the formulation. Equally important is the effect of concurrent food intake on the bioavailability of poorly soluble compounds. The effect of food on the bioavailability of compounds formulated in lipid and surfactant based formulations is also reviewed.",
keywords = "Former Faculty of Pharmaceutical Sciences",
author = "Dimitrios Fatouros and Karpf, {Ditte M} and Nielsen, {Flemming S} and Anette Mullertz",
year = "2007",
language = "English",
volume = "3",
pages = "591--604",
journal = "Therapeutics and Clinical Risk Management (Print)",
issn = "1176-6336",
publisher = "Dove Medical Press Ltd",
number = "4",

}

RIS

TY - JOUR

T1 - Clinical studies with oral lipid based formulations of poorly soluble compounds

AU - Fatouros, Dimitrios

AU - Karpf, Ditte M

AU - Nielsen, Flemming S

AU - Mullertz, Anette

PY - 2007

Y1 - 2007

N2 - This work is an attempt to give an overview of the clinical data available on lipid based formulations. Lipid and surfactant based formulations are recognized as a feasible approach to improve bioavailability of poorly soluble compounds. However not many clinical studies have been published so far. Several drug products intended for oral administration have been marketed utilizing lipid and surfactant based formulations. Sandimmune((R)) and Sandimmune Neoral((R)) (cyclosporin A, Novartis), Norvir((R)) (ritonavir), and Fortovase((R)) (saquinavir) have been formulated in self-emulsifying drug delivery systems (SEDDS). This review summarizes published pharmacokinetic studies of orally administered lipid based formulations of poorly aqueous soluble drugs in human subjects. Special attention has been paid to the physicochemical characteristics of the formulations, when available and the impact of these properties on the in vivo performance of the formulation. Equally important is the effect of concurrent food intake on the bioavailability of poorly soluble compounds. The effect of food on the bioavailability of compounds formulated in lipid and surfactant based formulations is also reviewed.

AB - This work is an attempt to give an overview of the clinical data available on lipid based formulations. Lipid and surfactant based formulations are recognized as a feasible approach to improve bioavailability of poorly soluble compounds. However not many clinical studies have been published so far. Several drug products intended for oral administration have been marketed utilizing lipid and surfactant based formulations. Sandimmune((R)) and Sandimmune Neoral((R)) (cyclosporin A, Novartis), Norvir((R)) (ritonavir), and Fortovase((R)) (saquinavir) have been formulated in self-emulsifying drug delivery systems (SEDDS). This review summarizes published pharmacokinetic studies of orally administered lipid based formulations of poorly aqueous soluble drugs in human subjects. Special attention has been paid to the physicochemical characteristics of the formulations, when available and the impact of these properties on the in vivo performance of the formulation. Equally important is the effect of concurrent food intake on the bioavailability of poorly soluble compounds. The effect of food on the bioavailability of compounds formulated in lipid and surfactant based formulations is also reviewed.

KW - Former Faculty of Pharmaceutical Sciences

M3 - Journal article

C2 - 18472981

VL - 3

SP - 591

EP - 604

JO - Therapeutics and Clinical Risk Management (Print)

JF - Therapeutics and Clinical Risk Management (Print)

SN - 1176-6336

IS - 4

ER -

ID: 9016756